ARM: Axillary Reverse Mapping

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Little Rock,
Arkansas72205

Purpose:

We hypothesize that variations in anatomic location of the arm lymphatic drainage system put
the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping
the drainage of the arm during the procedure would decrease the likelihood of inadvertent
disruption of the lymphatics and the subsequent development of lymphedema. A combination of
radioactivity and blue dye will be used.

Study summary:

Mapping Procedure:
Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the
normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or
around the tumor.
If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye
will be used in the breast either in the subareolar plexus or peritumorally at the
discretion of the surgeon. For this contingency (expected to occur <3% of the time), the
blue dye will be used in the breast (and NOT the arm), as the prime concern is locating the
SLN for staging.
If the blue dye is unnecessary to find the sentinel node draining from the breast, then it
will be injected dermally in the upper inner arm along the Biceps groove of the ipsilateral
arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye
will be injected in either the subareolar plexus, peritumorally (intraparenchymal or
dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies
stated above. Site of all injections (radioactivity and/or blue dye) will be recorded.

Criteria:

Inclusion Criteria:
- 18-100 years old
- Not pregnant or breastfeeding
- Breast cancer requiring lymph node evaluation for the ipsilateral or contralateral
breast OR prophylactic mastectomy
- Willing participation following an informed consent process
Exclusion Criteria:
- Patient < 18 y/o or > 100 y/o
- Pregnant or breastfeeding
- If a pregnant female should be diagnosed with breast cancer an exception would be
considered on a case to case basis.

NCT ID:

NCT00572481

Primary Contact:

Principal InvestigatorV. Suzanne Klimberg, MDUniversity of Arkansas

Backup Contact:

N/A

Location Contact:

Little Rock, Arkansas 72205United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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